Serialization and Treacebility solution for all requirements in Lifescience.

CureSync is enterprise level, flexible, easily integrated, high quality solution that is responding to the needs of all parties in pharmaceutical supply chain and to all known regulatory requirements accordingly.

Creative, adaptive and ever-ready solutions.

Serialization System 2.0...

...is built after a careful analysis of clients’ perspectives about the real-life challenges and requirements regarding the implementation of a serialization system, Track and Trace and managing serialized items. CureSync covers L2-L5 levels of pharmaceutical serialization.

Serialization & Traceability

Serialization is unique labelling of an object, facilitating its authorization and verification, to allow it to be recognized through the entire supply chain

Serialization is a foundational piece of a track and trace system.

To fulfill serialization requirements, you have to be able to:

Uniquely identify each item on a global level

Use random generation of unique identification numbers

Be able to perform decommission of unique identifiers before providing items to customers/patients

Verify/confirm items in national systems.

Support track and trace movements based on regulation

Fulfill your markets demands

Also, it is not enough for your solution to only be legislative in certain countries, if you are working on more than one market it is recommendable to have a solution that fits them all and the solution has to be easy to integrate to National repository systems.

CureSync enables you satisfy all current and upcoming regulations with flexible, expandable worldwide leading solution at affordable price. Optimizes investment in HW equipment, maintenance and internal skills and resources, GAMP5 validation and long term maintenance and support.

What is TradeTicity value proposition for MAH?

CureSync enables you satisfy all current and upcoming regulations with flexible, expandable worldwide leading solution at affordable price.

Optimizes investment in HW equipment, maintenance and internal skills and resources, GAMP5 validation and long term maintenance and support.

By choosing TradeTicity MAH will get:

Immediate compliance with all required regulations

Easy integration with CMOs and supply chain partners

Ability to expand between different licencing and pricing models

GAMP 5 Validated system

Advanced list of functions and features satisfying any demand you may have

Most commonly manufacturers are operating on international market and their first and biggest challenge is to be legislative in all of their current and also potential markets since every country has adopted its own announced compliance laws. We chose to provide you with a solution that can be used for unlimited number of markets, that can match market specific requirements for each country you do business in. Consequently, you can be operational and legislative in as many markets as you need at the moment but also in the future.

Can I have 5 different solutions for 5 different markets?

Most commonly manufacturers are operating on international market and their first and biggest challenge is to be legislative in all of their current and also potential markets since every country has adopted its own announced compliance laws. We chose to provide you with a solution that can be used for unlimited number of markets, that can match market specific requirements for each country you do business in. Consequently, you can be operational and legislative in as many markets as you need at the moment but also in the future.

What can I do if the supply chain doesn’t fit to market requirements?

Many of the manufacturers have outsourced packaging and manufacturing to their CMO’s and packagers. As a manufacturer, you probably have a lot of CMO’s and there is a good chance that your CMO’s have their own CMO’s. If you want to be in order with pharmaceutical serialization every service provider needs to have established serialization process. In order to do so you have to have a solution which is flexible and integrative both in Typical environment as well as in Heterogenous environments with diversified IT and production equipment urges.

In order to continue your successful collaboration with your clients you should be prepared for upcoming serialization. Serialization will affect you in two ways. First of all is the equipment you use; you have to have lines that are able to fulfill serialization needs, but also you have to have system to exchange data demanded by your customer with them.

Can you continue your work without serialization solution?

Since majority of MAH companies are outsourcing manufacturing to CMO’s you are probably the first point of drug production. Although, you are not the one bearing direct responsibilities for compliance, your pharmaceutical clients are and they will ask you to fulfill their exact serialization needs. In order to continue your successful collaboration with your clients you should be prepared for upcoming serialization. Serialization will affect you in two ways. First of all is the equipment you use; you have to have lines that are able to fulfill serialization needs, but also you have to have system to exchange data demanded by your customer with them.

Can you have 5 different solutions for 5 different markets?

It is important that CMOs have the capability to meet international requirements, but must also be flexible enough to meet all of the differing requirements of their customers. CMO often needs the ability to be compliant with the different requirements from their external stakeholders and those of different countries.

Wholesalers in the whole world are obliged to adapt to different regulations and directives, for example EU FMD – Falsified medicines directive whose purpose is to prevent entering of a falsified medicine to a legal supply chain. Managing upstream and downstream as demanded in all regulations and/or acts (DSCSA, FMD, ANVISA…) in any group, regardless of its size is always challenging. Since wholesalers usually have a wide range of partners that vary from small pharmacies to large pharmaceutical companies, managing end to end verification and authorization process becomes extremely demanding and overall challenging issue.

Wholesalers have to keep records in the form of account purchases / sales, in computerized form or in any other form, having at least the minimum required information on each transaction through which the drug was received, shipped or supplied, depending on the country they work in or work for.

When the drug was received from other wholesaler, authorization carriers for wholesale of medicinal products have to check that the wholesalers who supplied the drug acted in accordance with the principles and good practices in the wholesale distribution of drugs. This includes checking if the wholesaler who supplied the drug is licensed for the wholesale distribution.

Are you able to:

Create aggregation schemas?

Perform all aggregation functions, from identifying the product, verifying packaging options, to the formation of the SSCC number to be printed on the packaging.

Perform deaggregation action on the package, returning items in the package and change the status to deaggregated.

Your solution has to be able to manage the aggregation and deaggregation of the products. Products at the item level, with its specific Product Identification number (GTIN, IFA PPN, Self-defined, etc.) are bundled into bigger packages. Bundling options may be several, e.g. packaging could be of 12 or 6 bottles of pills on first level, and then this can be further bundled. Each aggregation level should have separate Product number (e.g. GTIN), but if the manufacturer prefers not to define products with the standard GS1 principle, the system has to assign the product identification internally. However, some aggregation bundles can consist of different types of products, e.g. 6 pieces of one, and 6 pieces of different type of product, which is important when the system is used as distributor system.

This is CureSync

CureSync - all you need in serialisation

Curesync is Enterprise Solution on Cloud Principles – multiinstance/multitenant/ webservice enables easy alignment with the most demanding environments, across your organization. The CureSync Serialization System 2.0 is built after a careful analysis of clients’ perspectives about the real-life challenges and requirements regarding the implementation of a serialization system, Track and Trace and managing serialized items.

In order to satisfy the demands from different clients, from extremely small with simple production, via distribution and logistics channels, to extremely complex, multinational organizations operating in multiple countries with diverse regulatory requirements.

Complexity Reduction

Easy System Integration

All Standards Supported

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